FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Medical Devices

FDA Warns Inova Genomics Lab on Illegal Genetic Tests

FDA warns Inova Genomic Tests about illegally marketing genetic tests intended to predict how consumers will respond to specific drugs.

Human Drugs

FDA Clears Magstim Theta Burst Stimulation

FDA clears a Magstim 510(k) to include intermittent Theta Burst Stimulation as a treatment for Major Depressive Disorder with its Horizon TMS Therapy ...

Looking Back at Gottlieb, Ahead to Sharpless

A Health Affairs article assesses Scott Gottliebs tenure as FDA commissioner in light of three drug policy initiatives and looks ahead to the arrival ...

Gottlieb to Tackle Drug Prices at AEI

Departing FDA commissioner Scott Gottlieb tells the Washington Post he will be returning to the American Enterprise Institute to study ways to reduce ...

Animal Drugs

FDA Releases Animal Product Adverse Reports

FDA says it is releasing 30 years of animal medical product adverse events reports and will update the online database quarterly.

Human Drugs

Groups Want Old Mifeprex Labeling Restored

Two pro-life medical groups ask FDA to return Mifeprex labeling to its 2000 provisions, overturning changes made in 2016.

Human Drugs

FDA Authorizes 1st Parallel REMS

Attorney Sara Koblitz says FDA approved a parallel REMS system for one of four generic manufacturers of Gileads Letairis.

Federal Register

Hearing on Developing Affordable Insulin Products

Federal Register notice: FDA announces a 5/13 public hearing to discuss access to affordable insulin products and issues related to the development an...

Federal Register

ChlorTrimeton Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Bayers ChlorTrimeton Allergy 12 Hour (chlorpheniramine maleate) extended release tablets 8mg and 12mg wer...

Federal Register

Onfi Not Withdrawn Due to Safety/Efficacy: FDA

Federal Register notice: FDA determines that Lundbeck Pharmaceuticals Onfi (clobazam) tablets 5mg were not withdrawn from sale for reasons of safety o...